A study to calculate efficacy and safety of SAR441566 in adults with rheumatoid arthritis

Phase 2

• Conditions: Health Condition 1: M068- Other specified rheumatoid arthritis

• Registration Number: CTRI/2024/05/067017
• Lead Sponsor: Sanofi Healthcare India Pvt Limited (SHIPL)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 27 May 2024

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. At least 18 years old (or the legal age of consent in the jurisdiction in which the study is taking place) at the time of signing the informed consent.

2. Diagnosis of adult-onset RA classified by ACR/EULAR 2010 revised classification criteria for RA (28) of at least 3 months duration, with the onset of signs and symptoms of RA of at least 6 months duration.

3. Moderate-to-severely active RA, defined as:

-- Persistently active disease more than equal to 6 tender and more than equal to 6 swollen joints.

-- High sensitivity C-reactive protein more than 5 mg/L.

4. Participants who stopped biologic treatment due to non-response, partial response, loss of efficacy (e.g., failure to achieve or maintain remission (IGA 0, clear skin to 2, mild disease)) must have been previously treated with biologic (at labelled dose level) for at least 4 months, as confirmed by investigator judgment.

5. Continuous treatment with MTX for at least 12 consecutive weeks prior to randomization and with stable dose/means of administration at least 6 weeks prior to the screening visit.

--MTX – 10 to 25 mg/week (or per local labeling requirements for the treatment of RA if the dose range differs, eg, for Japan, a stable dose of MTX is 6 to 16 mg/week) and folic/folinic acid (as part of MTX regimen).

6. BMI within the range (18 - 35) kg/m2 (inclusive).

7. All contraceptive methods used by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies

8. Male participants Male participants are eligible to participate if they agree to the following during the study treatment period and for at least 3 months after the last administration of study IMP: - Refrain from donating or cryopreserving sperm; PLUS, either: - Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent; OR - Must agree to use contraception as detailed below: A male condom and an additional highly effective contraceptive method (as described in Section 10.4), when having sexual intercourse with a woman of childbearing potential (WOCBP) who is not currently pregnant.

9. Female participants A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies:- Is a woman of nonchildbearing potential (WONCBP) as defined in the protocol; OR - Is a woman of childbearing potential (WOCBP) and agrees to use a contraceptive method that is highly effective (with a failure rate of less than 1percent per year), preferably with low user dependency (as described in Section 10.4) during the study intervention period (to be effective before starting the intervention) and for at least 3 months after the last administration of study intervention and agrees not to donate or cryopreserve eggs (ova, oocytes) for the purpose of reproduction during this period.

A WOCBP must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations%2

Exclusion Criteria

1. Immunologic disorder other than RA, with the exception of secondary Sjogrens syndrome associated with RA, and medically controlled diabetes or thyroid disorder as per Investigators judgement.

2. Any condition requiring oral, intravenous, IM, or intra-articular glucocorticoid therapy.

3. Uncontrolled polymyalgia rheumatica or fibromyalgia

4. History of recurrent or recent serious infection (eg, pneumonia, septicemia) or infection(s) requiring hospitalization or treatment with IV anti-infectives (antibiotics, antivirals, antifungals, antihelminthics) within 30 days prior to D1. Infections(s) requiring oral antiinfectives (antibiotics, antivirals, antifungals, antihelminthics) within 14 days prior to D1

5. Known history of or suspected significant current immunosuppression, including history of invasive opportunistic or helminthic infections despite infection resolution or otherwise recurrent infections of abnormal frequency or prolonged duration

6. History of moderate-to-severe congestive heart failure (NYHA Class III or IV), recent cerebrovascular accident, or any other condition in the opinion of the Investigator that would put the participant at risk by participation in the protocol.

7. History of solid organ transplant.

Study & Design

• Study Type: Interventional
• Study Design: Not specified